Events

Rappel de MultiDiagnost Eleva and MultiDiagnost Eleva with Flat Detector

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00342-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-23
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00342-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Philips has been made aware of instances in which the table of the multidiagnost-eleva has suddenly started to tilt from 0 to 90 degrees (table arm down) with high speed. the cause of this unexpected movement is related to an issue with the fixation of the upper and lower tilt actuator. in the event the system experiences uncontrolled movements, there is a risk of injury for the patient on the table. a tilting table might also hit the user or bystander standing near the system.
  • Action
    Philips is advising they will be in contact with users to replace affected components on the upper and lower tilt actuator in the impacted systems. In the interim, users should monitor the tables for any of the following, stop use of, and contact Philips immediately if they occur: · the table height or tilt movement is not working · a cracking or snapping sound is heard during system operation. · a blockade is experienced in the table height or tilt movement during system movements. · the system is having an unexpected collision or the system had an unexpected collision in the past 2 months. · a CPR stand that obstructed the system when in use, or · any (other) unusual system behaviour beyond the normal use of the system.

Device

MultiDiagnost Eleva and MultiDiagnost Eleva with Flat Detector
  • Modèle / numéro de série
    MultiDiagnost Eleva and MultiDiagnost Eleva with Flat DetectorSystem Code Numbers: 708032, 708034, 708036, 708037, 708038Model: MD-Eleva, UD-ElevaARTG Number: 98560Philips Electronics Australia - X-ray system, diagnostic, fluoroscopic, general-purpose, stationary, digital
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA